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Subject:
From:
Debra Swank <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Wed, 11 Nov 2020 16:54:03 -0500
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In response to the question on the nasal spray ketorolac and its safety for use during lactation, I find LactMed's website invaluable, as well as Hale and the InfantRisk Center.  

LactMed is part of the toxicology database from the U.S. National Institutes of Health, and the public can readily access the LactMed website by using the search term "LactMed".  Once into their website, you can enter the name of the medication in the search bar and immediately access the information.  

In looking up ketorolac on the LactMed website today, the most recent revision is listed as October 20, 2020.  I will share their information on ketorolac here, which is in the public domain.  Note that milk levels haven't yet been measured with the nasal spray, although helpful analysis has been done on oral, intramuscular, and intravenous routes as noted below.    

From LactMed: 
Summary of Use during Lactation:  Milk levels of ketorolac are low with the usual oral dosage, but milk levels have not been measured after higher injectable dosages or with the nasal spray. Ketorolac injection is used for a short time (typically 24 hours) after cesarean section in some hospital protocols with no evidence of harm to breastfed infants. A retrospective study found no difference in pain relief or breastfeeding outcome at discharge between a dose of 15 mg and 30 mg given intravenously within 15 minutes of at the end of surgery.[1] However, the ketorolac dose an infant receives in colostrum is very low because of the small volume of colostrum produced. Ketorolac has strong antiplatelet activity and can cause gastrointestinal bleeding. The manufacturer indicates that ketorolac is contraindicated during breastfeeding, so an alternate drug is preferred after the first 24 to 72 hours when larger volumes of milk are produced, especially while nursing a newborn or preterm infant.  Maternal use of ketorolac eye drops would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.  

Drug Levels:  Maternal Levels. Ten women who were 2 to 6 days postpartum and were taking ketorolac 10 mg orally four times daily had their milk ketorolac levels measured at various times during 2 days of drug administration. Milk levels were undetectable (<5 mcg/L) in 4 of the patients at all collection times. In the other 6 patients, ketorolac was detectable 2 hours after the first dose of the day in concentrations from 5.2 to 7.3 mcg/L on day 1 and from 5.9 to 7.9 mcg/L on day 2. Ketorolac was not detectable in milk in any patient at 10 hours after the last dose.[2] The paper erroneously states that the breastfed infant would receive an estimated 3.16 to 7.9 mg daily based on a calculation error. The correct calculation yields an estimated maximum daily intake of 7.9 mcg or 0.18% of the maternal weight-adjusted dosage.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants:  A randomized, double-blind study compared standard care of mothers receiving a cesarean section delivery (n = 60) to those receiving standard care plus multimodal pain management that included a single dose of 60 mg of intramuscular ketorolac given at the time of fascial closure (n = 60). No significant differences in abnormal neonatal growth, difficulty feeding, neonatal sedation, or respiratory depression rates between the two groups were seen during the first month postpartum.[3]

Effects on Lactation and Breastmilk:  A randomized, double-blind study compared standard care of mothers receiving a cesarean section delivery (n = 60) to those receiving standard care plus multimodal pain management that included a single dose of 60 mg of intramuscular ketorolac given at the time of fascial closure (n = 60). No significant differences in breastfeeding rates (78% and 79%, respectively) were seen during the first month postpartum.[3]

In a study comparing standard of care to enhanced recovery after cesarean section deliveries, a fixed dose of ketorolac 15 mg every 6 hours intravenously for 24 hours postpartum was part of the enhanced recovery protocol whereas as needed ketorolac 15 mg intravenously was part of the standard protocol. Patients in the enhanced recovery protocol (n = 58) had a greater frequency of exclusive breastfeeding (67%) than those in the standard protocol (48%; n = 60).[4]

A retrospective study evaluated 1349 women who had undergone a cesarean section and were given ketorolac within 15 minutes of the end of surgery. The results indicated that there was no difference in pain control in the first 6 hours after surgery nor in the percentage of women who were breastfeeding at discharge.[1]

Alternate Drugs to Consider:  (Systemic) Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen, Piroxicam

References
1.  Yurashevich M, Pedro C, Fuller M, et al. Intra-operative ketorolac 15 mg versus 30 mg for analgesia following cesarean delivery: A retrospective study. Int J Obstet Anesth. 2020;44:116–21. [PubMed]
2. Wischnik A, Manth SM, Lloyd J, et al. The excretion of ketorolac tromethamine into breast milk after multiple oral dosing. Eur J Clin Pharmacol. 1989;36:521–4. [PubMed]
3. Hadley EE, Monsivais L, Pacheco L, et al. Multimodal pain management for cesarean delivery: A double-blinded, placebo-controlled, randomized clinical trial. Am J Perinatol. 2019;36:1097–105. [PubMed]
4. Teigen NC, Sahasrabudhe N, Doulaveris G, et al. Enhanced recovery after surgery at cesarean delivery to reduce postoperative length of stay: A randomized controlled trial. Am J Obstet Gynecol. 2020;222:372.e1–372.e10. [PubMed]

https://www.ncbi.nlm.nih.gov/books/NBK500998/


With kind regards,

Debbie

Debra Swank, RN BSN IBCLC
Program Director
More Than Reflexes Education
Elkins, West Virginia USA
http://www.MoreThanReflexes.org

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